Harvard Clinical Research Institute, Boston VA Healthcare System, Boston, MA, USA.
Circulation. 2011 Nov 1;124(18):1964-72. doi: 10.1161/CIRCULATIONAHA.111.040022. Epub 2011 Oct 3.
Background- Transcatheter aortic valve replacement (TAVR) has been shown to improve survival compared with standard therapy in patients with severe aortic stenosis who cannot have surgery. The effects of TAVR on health-related quality of life have not been reported from a controlled study. Methods and Results- The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgical valve replacement to TAVR (n=179) or standard therapy (n=179). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the 12-item Short Form-12 General Health Survey (SF-12). The primary end point was the KCCQ overall summary score (range, 0-100; higher=better). At baseline, mean KCCQ summary scores (35±20) and SF-12 physical summary scores (28±7) were markedly depressed. Although the KCCQ summary score improved from baseline in both groups, the extent of improvement was greater after TAVR compared with control at 1 month (mean between-group difference, 13 points; 95% confidence interval, 8-19; P<0.001) with larger benefits at 6 months (mean difference, 21 points; 95% confidence interval, 15-27; P<0.001) and 12 months (mean difference, 26 points; 95% confidence interval, 19-33; P<0.001). At 12 months, TAVR patients also reported higher SF-12 physical and mental health scores with mean differences compared with standard care of 5.7 and 6.4 points, respectively (P<0.001 for both comparisons). Conclusions- Among inoperable patients with severe aortic stenosis, compared with standard care, TAVR resulted in significant improvements in health-related quality of life that were maintained for at least 1 year. Clinical Trials Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
背景-经导管主动脉瓣置换术（TAVR）已被证明可改善不能接受手术的重度主动脉瓣狭窄患者的生存率，优于标准治疗。TAVR 对健康相关生活质量的影响尚未从对照研究中报道。
方法和结果-主动脉瓣经导管置换术（PARTNER）试验将有症状的重度主动脉瓣狭窄且不能接受手术瓣膜置换的患者随机分为 TAVR 组（n=179）或标准治疗组（n=179）。使用堪萨斯城心肌病问卷（KCCQ）和 12 项简明健康调查 12 项量表（SF-12）在基线和 1、6 和 12 个月时评估健康相关生活质量。主要终点是 KCCQ 总综合评分（范围 0-100；越高越好）。在基线时，KCCQ 综合评分（35±20）和 SF-12 身体综合评分（28±7）明显降低。尽管两组的 KCCQ 综合评分均从基线开始改善，但 TAVR 组的改善程度大于对照组，在 1 个月时（组间差异平均 13 分；95%置信区间 8-19；P<0.001）差异更大，6 个月时（平均差异 21 分；95%置信区间 15-27；P<0.001）和 12 个月时（平均差异 26 分；95%置信区间 19-33；P<0.001）。在 12 个月时，TAVR 患者还报告了更高的 SF-12 身体和心理健康评分，与标准护理相比，平均差异分别为 5.7 和 6.4 分（两者比较均 P<0.001）。
结论-在不能手术的重度主动脉瓣狭窄患者中，与标准治疗相比，TAVR 可显著改善健康相关生活质量，且至少持续 1 年。
